Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-11 are presented for examination.
Claims 34-39 are withdrawn from examination.
Restriction/Election
Applicant’s election without traverse of Group I, claims 1-11 in the reply filed on 01/20/2026 is acknowledged.
Claims 34-39 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/20/2026.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The claims are drawn to a composition comprising: a complex including: micelles formed of amphiphilic molecules in which a hydrophilic portion and a hydrophobic portion are bound by a reactive oxygen species (ROS) cleavable linker; and manganese oxide particles which are supported on cores of the micelles and hydrophobically modified by binding a hydrophobic substituent to the surface thereof.
Claim(s) 1-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhu et al.(CN 107320738) in view of Sun et al. (A ROS-responsive polymeric micelle with a π-conjugated thioketal moiety for enhanced drug loading and efficient drug delivery) (Submitted by the applicant) and further in view of Hou (US 20190247524).
The claims are drawn to a composition comprising: a complex including: micelles formed of amphiphilic molecules in which a hydrophilic portion and a hydrophobic portion are bound by a reactive oxygen species (ROS) cleavable linker; and manganese oxide particles which are supported on cores of the micelles and hydrophobically modified by binding a hydrophobic substituent to the surface thereof.
Regarding claim 1, Zhu teaches a composition comprising a hydrophobic Mn3O4 particles comprising a hydrophobic portion and a hydrophilic portion bounded by a disulfide ROS-cleavable linker. Zhu teaches that the Mn3O4-LA nanometer is alpha-LA modified by oleic acid hydrophobic Mn3O4 nanometer particles. See The abstract. Zhu teaches that the lactalbumin micelle can be used as drug carrier loaded with hydrophobic drug molecule. On the other hand, alpha-lactalbumin chain has four disulfide bonds, by reducing agent cutting disulfide bond can be obtained free of mercapto, and after forming LA micelle capable of crosslinking to form a new disulfide bond, can improve the stability of micelle as a drug carrier. See the Background Technology, Para [2]. Zhu teaches that the surface of the hydrophobic Mn3O4 nanometer particle is modified with oleic acid. See section 2 of nanometer ball preparation. Zhu does not teach the manganese oxide being in the core of the micelles. However, Hou teaches a polymer-metal oxide complex, comprising a metal oxide particle located in the core and a polymer modified on the surface of the metal oxide particle. See the abstract. Hou teaches that the metal oxide is selected from the group consisting of iron oxide, manganese oxide, cobalt oxide, chromium oxide, and nickel oxide. See Para [0016]. It would have been obvious to a person skilled in the art to use manganese oxide of Zhu in the core of micelles, motivated by the teachings of Hou, which teaches the use of manganese oxide in the core of manganese oxide micelles.
Regarding claim 2, Zhu does not teach wherein the active oxygen cleavable linker is a thioketal. Sun teaches the use of ROS-responsive thioketal was introduced into the micelles as a linker, which was designed to speed up the drug release and thus enhance the therapeutic activity. See the abstract. It would have been obvious to a person skilled in the art to use thioketal linker in the composition of Zhu, motivated by the teaching of Sun, which teaches the use of thioketals as a linker speeds up the drug delivery and enhances the therapeutic activity.
Regarding claims 3 and 4, Zhu teaches that the surface of the hydrophobic Mn3O4 nanometer particle is modified with oleic acid. See section 2 of nanometer ball preparation. The number carbons in oleic acid is 18, which falls within the claimed scope of C12-C22.
Regarding Claims 5 and 6, Zhu does not teach wherein the hydrophilic portion of amphiphilic molecule includes a water soluble polymer. However, Hou teaches a polymer-metal oxide complex, comprising a metal oxide particle located at the core and a polymer modified on the surface of the metal oxide particle. See the abstract. Hou teaches polymer is selected from the group consisting of polyacrylic acid, polyacrylate salt, methyl polyacrylic acid, methyl polyacrylate, polylactic acid, polylactic acid salt and polyphosphoric ester. See Para [0011]. Hou teaches that the metal oxide is selected from the group consisting of iron oxide, manganese oxide, cobalt oxide, chromium oxide, and nickel oxide. See Para [0016]. It would have been obvious to add a water soluble polymer to the composition of Zhu, motivated by Hou, which teaches the addition of a polymer to a metal oxide, such as manganese oxide as old and well known.
Regarding claims 7 and 8, Zhu teaches the surface of the hydrophobic Mn3O4 nanometer particle is modified with oleic acid. See section 2 of nanometer ball preparation. The number carbons in oleic acid is 18, which falls within the claimed scope of C12-C22.
Regarding claim 9, Zhu teaches a composition comprising a hydrophobic Mn3O4 particles comprising a hydrophobic portion and a hydrophilic portion bounded by a disulfide ROS-cleavable linker. Zhu teaches that manganese oxide is Mn3O4.
Regarding claim 10, Zhu teaches the surface of the hydrophobic Mn3O4 nanometer particle is modified with oleic acid making the particle size of < 10 nm. See section 2 of nanometer ball preparation. Zhu Does not teach the particle diameter of 10 nm to 30 nm. However, the determination of optimum particle size is considered to be within the skill of artisan in the absence of evidence to the contrary.
Regarding claim 11, Zhu teaches that the lactalbumin micelle can be used as drug carrier loaded with hydrophobic drug molecule. See the Background Technology, Para [2].
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZOHREH A FAY whose telephone number is (703)756-1800. The examiner can normally be reached Monday-Friday 9:30AM-6:00.
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/ZOHREH A FAY/Primary Examiner, Art Unit 1617
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